AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis

• ClinicalTrials.gov Identifier: NCT04721717
• Recruitment Status: Recruiting
• First Posted: January 25, 2021
• Last Update Posted: March 9, 2023
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Hon K. Yuen, PhD, University of Alabama at Birmingham

Study Description

Brief Summary:

The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury.

Condition or disease
Spinal Cord Injuries

Detailed Description:

Because of the inability to move certain parts of the body, persons with paralysis caused by neurological conditions such as spinal cord injury, traumatic head injury, and stroke experience grief from the loss of physical capacity, social or occupational role function, and life goals. Common complications associated with grief in these individuals include increased anxiety and depression, poor physical health, and low sense of purpose in life. Therefore, it is essential to identify community-based, self-help support that can serve as a step to facilitate healthy grieving in these individuals. Such support should aim at shifting their mindset from focusing on their loss (disability) to restoring daily function. Constructing and reconstructing the story of one's own life has been reported in several autobiographic accounts as a coping strategy to learn acceptance and how to live with various traumatic conditions (i.e., grief resolution).

Writing about emotionally traumatic or challenging experiences has been shown to have a surprisingly beneficial effect on reports of symptom reduction and health care use, as well as improvements in health status and well-being in people with chronic conditions. Expressive emotional writing programs have demonstrated the ability to improve the quality of life of individuals with chronic conditions. Although expressive writing could be a promising avenue in reducing grief and improving psychosocial and physical functioning among adults with paralysis, currently, few programs on expressive emotional writing are available for these individuals. Therefore, the UAB Institute for Arts in Medicine (AIM) will implement an innovative expressive emotional writing pilot project for adults with paralysis.

To maximize the number of adults with paralysis who can benefit from participating in this expressive emotional writing program, the investigators will partner with two additional organizations -the Is-Able Center and the Lakeshore Foundation in Birmingham, Alabama. The Is-Able Center (https://isable.org/) is a non-profit community organization which provides services including grief support that encourage, educate and empower the quality of life for individuals with disabilities. The Lakeshore Foundation (https://www.lakeshore.org/) is also a non-profit community organization that serves and advocates for people with physical disabilities.

The writing program will take place at both the Is-Able Center and Lakeshore Foundation starting in July 2020. The program will run for 10 consecutive weeks, with weekly writing activities. The grant funds will be used to reimburse mileage for adults with paralysis for participation in the writing program, hire a program coordinator, and two coaches to facilitate the writing program and facilitate discussion conducted in each of the two community organizations.

Study Design

• Study Type: Observational
• Estimated Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: March 28, 2025
• Estimated Study Completion Date: March 28, 2025

Groups and Cohorts

Group/Cohort
People with SCI; People with paraplegia and quadriplegia

Outcome Measures

Primary Outcome Measures :

1. The Grief and Loss Scale [ Time Frame: 11 Weeks ]
   (Kalpakjian et al., 2015) is a 9-item measure of an individual's emotional reactions or grief such as anger, guilt, anxiety, sadness, and despair in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 9 to 45. Higher scores reflect higher degree of grief and loss.
2. Emotional Distress - Depression [ Time Frame: 11 Weeks ]
   Short Form 8b. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is an 8-item measure of an individual's emotional distress (depression) in the past 7 days, using a 5-point scale (1=never) to 5 (always). The scores range from 8 to 40. Higher scores reflect higher degree of emotional distress (depression)
3. Perceived Stress Scale [ Time Frame: 11 Weeks ]
   PSS) (Cohen et al. 1988) is a 10-item measure of frequency of an individual experiencing stress in the past month, using a 5-point scale (1=never) to (5=very often). Four positively stated items require reversed coding. The scores range from 10 to 50. Higher scores reflect higher frequency of experiencing stress.
4. Impact of Events Scale [ Time Frame: 11 Weeks ]
   (Weiss, 2007). It is a 6-item measure of an individual's distress related to different difficulties in the past 7 days, using a 5-point scale (0=not at all) to 4 (extremely). The scores range from 0 to 24. Higher scores reflect greater distress.
5. Meaning and Purpose [ Time Frame: 11 Weeks ]
   It is part of the NIH Toolbox Item Bank. It is a 7-item measure of an individual's meaning and purpose in life, using a 5-point scale (1=strongly disagree) to 5 (strongly agree). The scores range from 7 to 35. Higher scores reflect greater meaning and purpose in life.
6. Self-Efficacy for Managing Chronic Conditions - Managing Emotions [ Time Frame: 11 Weeks ]
   Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's self-efficacy for managing chronic conditions, using a 5-point scale (1=I am not at all confident) to 5 (I am very confident). The scores range from 4 to 20. Higher scores reflect greater confident in managing chronic conditions.
7. Sleep Disturbance [ Time Frame: 11 Weeks ]
   Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's sleep problem or quality in the past 7 days, using a 5-point scale (1=not at all/very much) to 5 (very much/very poor). Two positively stated item require reversed coding. The scores range from 4 to 20. Higher scores reflect greater sleep problem.
8. Sleep Impact [ Time Frame: 11 Weeks ]
   Short Form. It is a part of the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ). It is a 5-item measure of an individual's trouble falling asleep in the past 7 days, using a 5-point scale (1=always) to 5 (never). One positively stated item require reversed coding. The scores range from 5 to 25. Higher scores reflect less trouble falling asleep.
9. Ability to Participate in Social Roles and Activities [ Time Frame: 11 Weeks ]
   Short Form 4a. It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's trouble participating in social roles and activities, using a 5-point scale (1=always) to 5 (never). The scores range from 4 to 20. Higher scores reflect less trouble participating in social roles and activities.
10. Satisfaction with Social Roles and Activities [ Time Frame: 11 Weeks ]
    It is a part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It is a 4-item measure of an individual's satisfaction with social roles and activities, using a 5-point scale (1=not at all) to 5 (very much). The scores range from 4 to 20. Higher scores reflect greater satisfaction with social roles and activities.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Sex: both Race/Ethnicity: all Age: aged 18 years or above Health status: Healthy

Criteria

Inclusion Criteria:

1. Age 18 or older with paralysis living in the community
2. limb paralysis resulting from a traumatic event/accident or neurological disease (e.g., spinal cord injury, head injury, stroke, multiple sclerosis, poliomyelitis, peripheral neuropathy, Parkinson's disease, ALS, botulism, and Guillain-Barré syndrome etc) happened after childhood
3. a non-traumatic spinal cord injury may be caused by arthritis, cancer, inflammation, infections or disk degeneration of the spine
4. able to communicate verbally or through writing

Exclusion Criteria:

1. known maladaptive behavioral patterns, exhibition of overt psychotic symptoms (e.g., presence of hallucinations, delusions, or thought disorders)
2. congenital (e.g., spinal bifida, cerebral palsy)

Contacts and Locations

Locations

United States, Alabama

354 School of Health Professions Building; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Hon Yuen, PhD 205-934-6301 yuen@uab.edu

Principal Investigator: Hon Yuen, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

• Responsible Party: Hon K. Yuen, PhD, Professor of Occupational Therapy, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04721717
• Other Study ID Numbers: IRB- 300005546
• First Posted: January 25, 2021
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Paralysis; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations